International Medical Device Regulatory Monitor
April 2012 | Vol. 20 No. 4 | Full Issue in PDF Format
Devicemakers should have an easier time filing field safety and corrective action (FSCA) reports in the EU, thanks to new report forms in a revised guideline on medical device vigilance systems.
The next incarnation of the EU’s medical device directives may include provisions on the risk classification, labeling and instructions for use of medical devices containing nanomaterials, according to a government panel of scientific experts.
The EU’s Scientific Committee on Emerging and Newly Identified Health Risks will prepare a questionnaire for women who received the PIP silicone gel breast implants, to be distributed by member states.
Early goals of the newly formed International Medical Device Regulators Forum (IMDRF) include defining a common international “table of contents” for electronic submissions and designing a roadmap for implementation of a unique device identification system.
An uptick in centralized purchasing of medtech products in the EU threatens to depress prices, reduce innovation and lock out smaller suppliers, a Eucomed study finds.
Beginning March 1, 2013, devicemakers in the EU will have the option of providing electronic information for use (eIFU) to customers of certain groups of medical devices. Includes the full text of EU's Electronic IFU Regulation.
Simply translating a medical device’s instructions for use (IFU) from the original language into Chinese will likely land foreign devicemakers in the regulatory hot seat, according to Vic Zhang, director of regulatory affairs-China for Smith & Nephew’s Advanced Surgical Devices Division.
The Malaysian government has enacted separate laws to create a medical device authority (MDA) and establish a comprehensive regulatory framework for devices and in vitro diagnostic (IVD) devices.
Patent reform legislation approved by the Australian Parliament March 20 includes a “research use exemption,” allowing those who don’t hold the patent to conduct research on patented products without fear of prosecution for infringing those patents.
The U.S. Supreme Court’s March 20 decision on the patent eligibility of a diagnostic could have ramifications for in vitro diagnostic devicemakers, limiting investment in novel tests because of uncertainty about what is and is not patentable, a U.S. patent attorney tells IMDRM.
Starting June 5, devicemakers audited according to internationally harmonized regulatory standards could be spared some annual U.S. Food and Drug Administration (FDA) inspections, under a pilot program described in a final guidance.
The UK’s Medical and Healthcare products Regulatory Agency (MHRA) issued an updated alert to medical professionals on managing patients with metal-on-metal (MoM) implants — the same day a British Medical Journal (BMJ) article said the hips may have exposed “hundreds of thousands of people globally” to toxic metal ions.
The U.S. Food and Drug Administration (FDA) will consider adding a mandatory pre-522 discussion period before issuing postmarket surveillance orders, officials at a March 7 FDA public workshop on the process said.
A new draft guidance outlining expectations for presubmission meetings with the U.S. Food and Drug Administration (FDA) is expected in the next few months, regulators said during a March 5 Regulatory Affairs Professionals Society meeting.
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